Piercing of body parts and skin portions thereof takes place frequently and occurs either manually or by means of some kind of instrument. The best known and most used instruments are specially adapted to piercing of ear lobes and can be divided into hand-operated and spring-operated instruments. An example of the former is given is U.S. Pat. No. 5,792,170 and an example of the latter is given in EP 0 559 637.
In all surgical operations, including piercing and positioning pieces of jewelry in body parts, it is desirable to use products and methods which enable and facilitate aseptic handling. By asepsis is meant a process and technique which aim at preventing spreading of pathogenic microorganisms. Since piercing of body parts for insertion of pieces of body jewelry or ear jewelry is often performed by non-medically trained staff, products and methods with integrated asepsis, to prevent infection and spreading of infectious matter, are extremely important.
In some prior art instruments for ear piercing, loose sterile pieces of ear jewelry are used for piercing with associated locking means, often packed in pairs. From an aseptic point of view it is, however, preferred to have a sterile disposable cartridge comprising a piece of ear jewelry and an associated locking means, where only the sterile disposable cartridge will come close to the skin and the hole that is to be made, the cartridge being replaced with a new one after each individual piercing, and where before, during or after piercing the operator will not come into contact with or close to the piece of ear jewelry, locking means or the parts of the disposable cartridge that risk to be contaminated or may have been contaminated. Such a sterile disposable cartridge with an associated instrument is disclosed in EP 0 559 637. The construction and method described in EP 0 559 637 have the asepsis integrated in the system, but is mainly suited for ear piercing.
The prior art instruments for piercing ear lobes are, due to their construction, less suited or not suited at all for use on other body parts. Now follows an account of a number of reasons why existing products and methods for ear piercing are mainly suited for use in piercing of the ear and nothing else.
When piercing many other body parts, for example a navel, an operator grasps an originally substantially plane skin portion instead of a well-defined flap-like area such as an ear lobe. When piercing an ear lobe, basically only a desired entry hole therefore has to be determined, marked and aimed at, whereas in piercing other body parts, for instance a navel, both the desired entry hole and the desired exit hole have to be determined, marked and aimed at. When piercing an ear lobe with an instrument developed for this purpose, an entry hole is marked, after which the skin is disinfected. After that the operator takes aim at the mark using the tip of the piercing means, which with current technology is a sharp bar which is fixedly secured to the piece of ear jewelry or a cannula which is releasably connected to the piece of ear jewelry, after which the instrument is operated to press out the piercing means. By holding the instrument in a certain direction, the direction of the piercing means through the ear lobe is determined, and thus also the approximate location of the exit hole is obtained.
In manually piercing another body part, for instance a navel, both the desired entry hole and the desired exit hole are marked. After disinfection of the skin portion, a pair of tongs with gripping loops is used to squeeze the skin so that the entry and exit holes become visible in both loops of the pair of tongs. Then the operator must, by eye, aim the piercing means, which with current technology is a cannula separated from the piece of body jewelry or releasably connected thereto, or alternatively a sharp bar end of the actual piece of body jewelry, at the mark of the entry hole and, by eye, align the piercing means so that, when penetrating the skin portion, it will exit just in the mark made for the exit hole.
Another aspect which differs when piercing an ear lobe compared with piercing certain other body parts, for instance a navel, is the appearance of the piece of body jewelry which is preferred. When piercing an ear lobe, a piece of ear jewelry with a completely straight bar is generally preferred. This means that the motion that is required for positioning the piece of ear jewelry is completely linear. When piercing other body parts where the hole is done by pinching an originally substantially plane skin portion, for instance adjacent to a navel, a piece of body jewelry with a bent bar is preferred. The purely medical reason for this is that when piercing an originally substantially plane skin portion, a piece of body jewelry with a straight bar would cause more tension in the pierced body portion since the locking means and decorative member of such a piece of jewelry abut against the plane skin and act to press out the bar from the plane skin surface. On a short view, the risk of irritation and infection increases while in a somewhat longer view the risk increases that such a straight piece of jewelry is rejected and migrates out of the user's body. Purely cosmetically, the advantage is that in certain body parts, for instance a navel, a piece of body jewelry with a bent bar has a more attractive appearance. The design of the bar of the piece of body jewelry affects the requirements placed on the piercing process since insertion of a piece of body jewelry with a straight bar can take place by fully linear motions, whereas the insertion of a piece of body jewelry with a bent bar must take place by a non-linear motion.
The instruments and the sterile disposable products for piercing ear lobes which allow and simplify the use of asepsis are for, inter alia, the above reasons not suitable for use when piercing other body parts than precisely ears. Piercing of body parts and skin portions except ears often takes place using purely manually aids by the skin in the area in which piercing is to take place, for example a navel or an eye brow, being disinfected and squeezed by a squeezing means in the form of a pair of tongs with loops. Subsequently piercing takes place by the operator holding a piercing means in the form of a cannula directly with his fingers and manually pressing this through the skin portion through a marked desired entry hole and a marked desired exit hole respectively. In conjunction with pulling out of the cannula from the penetrated skin portion, or just after that, the piece of body jewelry is held directly with the operator's fingers, after which the bar of the piece of body jewelry is manually pressed through the resulting hole. It also happens that the cannula is mounted directly on the bar, whereby this is put in place while the cannula is being pressed through the skin portion, see for example U.S. Pat. No. 3,500,829.
To fasten the piece of body jewelry in the skin, a locking means is mounted on the free end of the bar. The locking means is usually mounted manually. For body jewelry, this usually takes place by a locking means in the form of a ball being held with the fingers and threaded onto the free end of the bar, which requires some dexterity of the operator since the locking means itself is small and has a fine internal thread. The mounting of the locking means also results in an inevitable contact with the skin portion around the piercing just made.
A common feature of these manual piercing methods is that they involve blood, that is the handling is such that it is practically impossible to prevent blood from being visible and exposed, which thus results in a serious risk of infection to the operator and discomfort to the individual who is being pierced. Another common feature is that these manual methods also comprise the step that the operator has to handle a sharp piercing means with his fingers, which, together with the exposure of blood, creates a serious risk of infection to the patient as well as to the operator. A further common feature is that the operator with his fingers comes into contact with the piece of body jewelry and/or its locking means, which thus constitutes another risk of infection. These risks of infection, of course, involve microorganisms which may cause serious wound infections, but the risks of infection also apply to deadly blood virus, such as HIV and hepatitis.
Summing up, the manual piercing methods pose great risks of spreading infectious matter and infection. It is true that with the above described products and methods it is possible to work aseptically, which, however, requires knowledge, experience, accuracy and staff resources.
Instruments are available, which are used to pinch the skin and then make the piercing means penetrate the skin, for instance those disclosed in GB 2 310 378 A and DE 198 16 841 A1. Also these instruments suffer from many of the drawbacks from the aseptic point of view as mentioned above.
A specific problem in piercing performed with a piercing means in the form of a loose sharp unit or with a sharp unit, such as a cannula, which is releasably connected to the bar of the piece of body jewelry, is that the handling of the piercing means used can pose a certain risk above all to the operator. However, there are solutions to this kind of problems.
A first variant is shown in U.S. Pat. No. 3,500,829 which discloses piercing of ear lobes, where the bar is provided with a cannula which after piercing is pressed into a cannula catcher which is held by the operator's one hand against the rear side of the ear lobe. Piercing is adapted to take place completely manually with the risks of infection and spreading of infectious matter that are involved.
A second solution is given in U.S. Pat. No. 5,709,700 which discloses an embodiment of a disposable instrument for piercing of ear lobes. The instrument comprises a cartridge containing a piece of ear jewelry, a cannula, a mechanism for receiving the cannula and a pressure mechanism. The pressure mechanism comprises a spring-loaded push rod by means of which the cannula, together with the bar arranged on the same, is pushed through the ear lobe. In this position, the cannula is pushed into and received against a two-piece spring-loaded cannula catcher. On completion of piercing, the cannula catcher springs up to expose the cannula which is then removed manually and arranged in a cannula compartment arranged in the cartridge. The instrument is designed for piercing of ear lobes and, like other instruments that are known for this purpose, is inconvenient for use on other parts of the body owing to all the circumstances that have been described above. Moreover the mechanical construction results in high costs of the disposable instrument. Further, although it is a disposable instrument, the document does not disclose a technique which is acceptable from the point of view of asepsis since the operator, after piercing, is forced to touch the cannula.
All the above described technical solutions and methods for piercing of ear lobes as well as other parts of the body also suffer from a drawback which affects safety in piercing. Two steps that are critical in piercing are performed at the same time or immediately in succession, which increases the risk of something going wrong in piercing. The step where the operator aligns the piercing means with the entry and, optionally, the exit hole, and the step where the operator performs the actual piercing through the skin portion must with all prior art techniques be performed in the same step or in two steps in close succession. As a result, the actual piercing step can be experienced by the operator to be dramatic. Moreover the risk of failure will always be greater when two critical steps are to be performed at the same time or in close succession.
There is thus a need for a technique for piercing body parts and skin portions which presents easy handling, which provides an aseptic technique with regard to both the person who is being pierced and the operator, which separates the sighting step from the piercing step, and which is not limited to use on a specific body part or a specific skin portion.